Agency Information Collection Activities: Submission to OMB for Review and Approval; Public Comment Request

Federal RegisterApr 8, 2013

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Health Resources and Services Administration

Agency Information Collection Activities: Submission to OMB for Review and Approval; Public Comment Request

ACTION:

Notice.

SUMMARY:

In compliance with section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995 (44 U.S.C. Chapter 35), the Health Resources and Services Administration (HRSA) will submit an Information Collection Request (ICR) to the Office of Management and Budget (OMB). Comments submitted during the first public review of this ICR will be provided to OMB. OMB will accept further comments from the public during the review and approval period. To request a copy of the clearance requests submitted to OMB for review, email

paperwork@hrsa.gov

or call the HRSA Reports Clearance Office at (301) 443-1984.

Information Collection Request Title: National Practitioner Data Bank for Adverse Information on Physicians and Other Health Care Practitioners—45 CFR Part 60 Regulations and Forms OMB No. 0915-0126—Revision

Abstract:

This is a request for a revision of OMB approval of the information collections contained in regulations found at 45 CFR part 60 governing the National Practitioner Data Bank (NPDB) and the forms to be used in registering with, reporting information to, and requesting information from the NPDB. Section 6403 of the Patient Protection and Affordable Care Act of 2010 (Affordable Care Act) Public Law 111-148 requires the transfer of all data in the Healthcare Integrity and Protection Data Bank

(HIPDB) to the NPDB. Data collection will not change; however, the merger will consolidate forms from OMB No. 0915-0239 for HIPDB under OMB No. 0915-0126 for NPDB. Responsibility for NPDB implementation and operation resides in the Bureau of Health Professions, Health Resources and Services Administration (HRSA), Department of Health and Human Services (HHS). Operation of the HIPDB was delegated by the HHS Office of the Inspector General to HRSA. This rule eliminates duplicative data reporting and access requirements between the HIPDB [established through the Health Insurance Portability and Accountability Act of 1996 (HIPPA) under Section 1128(b)(5) of the Social Security Act (42 U.S.C. 1320a-7e)] and the NPDB [established through the Health Care Quality Improvement Act of 1986 under Title IV (42 U.S.C. 11101

et seq.

) and expanded by Section 1921 of the Social Security Act (42 U.S.C. 1396r-2)]. Information previously collected and disclosed through the HIPDB will be collected and disclosed through the NPDB. Section 6403 of the Affordable Care Act consolidates the collection and disclosure of information from both data banks under Title 45 part 60 of the Code of Federal Regulations (CFR). HHS will subsequently remove Title 45 part 61, which implemented the HIPDB.

The intent of NPDB is to improve the quality of health care by encouraging hospitals, state licensing boards, professional societies, and other entities providing health care services, to identify and discipline those who engage in unprofessional behavior; and to restrict the ability of incompetent health care practitioners, providers, or suppliers to move from state to state without disclosure of previous damaging or incompetent performance. It also serves as a fraud and abuse clearinghouse for the reporting and disclosing of certain final adverse actions (excluding settlements in which no findings of liability have been made) taken against health care practitioners, providers, or suppliers by health plans, federal agencies, and state agencies.

The NPDB acts primarily as a flagging system; its principal purpose is to facilitate comprehensive review of practitioners' professional credentials and background. Information is collected from, and disseminated to, eligible entities (entities that are entitled to query and/or report to the NPDB under the three aforementioned statutory authorities) on the following: (1) Medical malpractice payments, (2) licensure actions taken by Boards of Medical Examiners, (3) state licensure and certification actions, (4) federal licensure and certification actions, (5) negative actions or findings taken by peer review organizations or private accreditation entities, (6) adverse actions taken against clinical privileges, (7) federal or state criminal convictions related to the delivery of a health care item or service, (8) civil judgments related to the delivery of a health care item or service, (9) exclusions from participation in federal or state health care programs, and (10) other adjudicated actions or decisions. It is intended that NPDB information should be considered with other relevant information in evaluating credentials of health care practitioners, providers, and suppliers.

The reporting forms and the request for information forms (query forms) are accessed, completed, and submitted to the NPDB electronically through the NPDB Web site at

http://www.npdb-hipdb.hrsa.gov/.

All reporting and querying is performed through this secure Web site.

Burden Statement:

Burden in this context means the time expended by persons to generate, maintain, retain, disclose or provide the information requested. This includes the time needed to review instructions, to develop, acquire, install and utilize technology and systems for the purpose of collecting, validating and verifying information, processing and maintaining information, and disclosing and providing information, to train personnel and to be able to respond to a collection of information, to search data sources, to complete and review the collection of information, and to transmit or otherwise disclose the information. The total annual burden hours estimated for this ICR are summarized in the table below.

The annual estimate of burden is as follows:

Regulation citation

Form name

Number of

respondents

Responses per

respondent

Total

responses

Hours per

response

Total burden hours

§ 60.6: Reporting errors, omissions, revisions or whether an action is on appeal

Correction, Revision to Action, Correction of Revision to Action, Void, Notice of Appeal

38,785

.25

9,696

§ 60.7: Reporting medical malpractice payments

Medical Malpractice Payment

14,193

.75

10,645

§ 60.8: Reporting licensure actions taken by Boards of Medical Examiners & § 60.9: Reporting licensure and certification actions taken by States

State Licensure

28,700

.75

21,525

§ 60.10: Reporting Federal licensure and certification actions

DEA/Federal Licensure

499

.75

374

§ 60.11: Reporting negative actions or findings taken by peer review organizations or private accreditation entities

Peer Review Organization

.75

Accreditation

.75

§ 60.12: Reporting adverse actions taken against clinical privileges

Title IV Clinical Privileges Actions

962

.75

722

Professional Society

.75

§ 60.13: Reporting Federal or State criminal convictions to the delivery of a health care item or service

Criminal Conviction (Guilty Plea or Trial)

1,023

.75

767

Deferred Conviction or Pre-Trial Diversion

126

.75

Nolo Contendere (No Contest) Plea

.75

Injunction

.75

§ 60.14: Reporting civil judgments related to the delivery of a health care item or service

Civil Judgment

.75

§ 60.15: Reporting exclusions from participation in Federal or State health care programs

Exclusion/Debarment

2,402

.75

1,802

§ 60.16: Reporting other adjudicated actions or decisions

Government Administrative

2,682

.75

2,012

Health Plan Action

561

.75

421

§ 60.18 Requesting Information from the NPDB

One Time Query for an Individual

986,552

.08

78,924

One Time Query for an Organization

18,892

.08

1,511

Self-Query on an Individual

154,824

.42

65,026

Self-Query on an Organization

1,095

.42

460

Continuous Query

387,767

.08

31,021

§ 60.21: How to dispute the accuracy of NPDB information

Subject Statement and Dispute

3,347

.75

2,510

Request for Secretarial Review

664

Administrative

Entity Registration (Initial)

35,915

Entity Registration (Renewal & Update)

15,461

.08

1,237

Agent Registration (Initial)

100

.25

Agent Registration (Renewal & Update)

100

.25

Electronic Transfer of Funds (EFT)Authorization

562

.25

141

Authorized Agent Designation

1,290

.25

323

Account Discrepancy

.25

Total

1,696,115

265,978

ADDRESSES:

Submit your comments to the desk officer for HRSA, either by email to

OIRA_submission@omb.eop.gov

or by fax to 202-395-5806. Please direct all correspondence to the “attention of the desk officer for HRSA.”

Deadline:

Comments on this ICR should be received within 30 days of this notice.

Dated: April 1, 2013.

Bahar Niakan,

Director, Division of Policy and Information Coordination.

[FR Doc. 2013-08071 Filed 4-5-13; 8:45 am]

BILLING CODE 4165-15-P

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